Search / Trial NCT00002406

A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Hiv 1 Dose Response Relationship, Drug Hiv Protease Inhibitors Indinavir Rna, Viral Reverse Transcriptase Inhibitors

ClinConnect Summary

In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Documented HIV-1 seropositive status.
  • CD4 count greater than 100 cells/mm3.
  • Parental consent for patients under 18.

About Merck Sharp & Dohme Llc

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.

Locations

Miami, Florida, United States

Chicago, Illinois, United States

Atlanta, Georgia, United States

Boston, Massachusetts, United States

Akron, Ohio, United States

San Francisco, California, United States

New York, New York, United States

Boston, Massachusetts, United States

Pittsburgh, Pennsylvania, United States

Sacramento, California, United States

Albany, New York, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Fort Lauderdale, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Bethesda, Maryland, United States

Detroit, Michigan, United States

Kansas City, Missouri, United States

Camden, New Jersey, United States

Voorhees, New Jersey, United States

Brooklyn, New York, United States

Flushing, New York, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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